Devices, systems and methods for medicament delivery

ABSTRACT

An apparatus includes a housing, a medicament container and an actuator. The actuator includes a release member and an energy storage member having a first position and a second position. In the first position, the energy storage member has a first potential energy. In the second position the energy storage member has a second potential energy. The energy storage member is configured to convert a portion of the first potential energy into kinetic energy when moved from the first position to the second position to move the medicament container within the housing. The energy storage member has a longitudinal axis offset from a longitudinal axis of the medicament container. The release member is configured to selectively deploy the energy storage member from its first position to its second position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 11/562,061, now U.S. Pat. No. 7,648,482, entitled“Devices, Systems and Methods for Medicament Delivery,” filed Nov. 21,2006, which is a continuation-in-part of U.S. patent application Ser.No. 10/515,571, now U.S. Pat. No. 7,416,540, entitled “Devices, Systemsand Methods for Medicament Delivery,” filed Nov. 23, 2004, which is anational stage filing under 35 U.S.C. §371 of International PatentApplication No. PCT/US2004/039386, entitled “Devices, Systems andMethods for Medicament Delivery,” filed Nov. 23, 2004, each of which isincorporated herein by reference in its entirety. U.S. patentapplication Ser. No. 11/562,061 is also a continuation-in-part of U.S.patent application Ser. No. 10/572,148, entitled “Devices, Systems andMethods for Medicament Delivery,” filed Mar. 16, 2006 now U.S. Pat. No.7,749,194, which is a national stage filing under 35 U.S.C. §371 ofInternational Patent Application No. PCT/US2006/003415, entitled“Devices, Systems and Methods for Medicament Delivery,” filed Feb. 1,2006, which claims priority to U.S. Provisional Application Ser. No.60/648,822, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Feb. 1, 2005 and U.S. Provisional Application Ser. No.60/731,886, entitled “Auto-Injector with Feedback,” filed Oct. 31, 2005,each of which is incorporated herein by reference in its entirety.

BACKGROUND

The invention relates generally to a medical device, and moreparticularly to an medicament delivery device for automaticallyinjecting a medicament into a body of a patient.

Exposure to certain substances, such as, for example, peanuts,shellfish, bee venom, certain drugs, toxins, and the like, can causeallergic reactions in some individuals. Such allergic reactions can, attimes, lead to anaphylactic shock, which can cause a sharp drop in bloodpressure, hives, and/or severe airway constriction. Accordingly,responding rapidly to mitigate the effects from such exposures canprevent injury and/or death. For example, in certain situations, aninjection of epinephrine (i.e., adrenaline) can provide substantialand/or complete relief from the allergic reaction. In other situations,for example, an injection of an antidote to a toxin can greatly reduceand/or eliminate the harm potentially caused by the exposure.

Because emergency medical facilities may not available when anindividual is suffering from an allergic reaction, some individualscarry an auto-injector to rapidly self-administer a medicament inresponse to an allergic reaction. Some known auto-injectors arecylindrical in shape and include a spring loaded needle to automaticallypenetrate the user's skin and inject the medicament. Such knownauto-injectors can be bulky and conspicuous, which can make carryingthem inconvenient and undesirable. Moreover, some known auto-injectorsdo not have a retractable needle and, as such, cause a sharps hazardwhen injection is complete.

Some known auto-injectors include a locking cap at the proximal end ofthe auto-injector to prevent inadvertent actuation and a needle cover atthe distal end of the auto-injector. Such a configuration can, at times,cause a user to become confused as to which end of the auto-injector isthe “needle end” (i.e., the distal end) and which end of theauto-injector is the “actuation end” (i.e., the proximal end). As such,in some situations, a user may mistakenly actuate the knownauto-injector away from the intended injection site. Such an error canresult, for example, in the auto-injector being actuated into the user'sthumb and/or finger.

Thus, a need exists for an auto-injector that can be more convenientlycarried by a user and does not present a sharps hazard upon completionof the injection. Furthermore, a need exists for an auto-injector thatcan be actuated from its distal end.

SUMMARY

Apparatuses and methods for automatic medicament injection are describedherein. In one embodiment, an apparatus includes a housing, a medicamentcontainer disposed within the housing and an actuator. The actuator isconfigured to be disposed within the housing and to move the medicamentcontainer within the housing. The actuator includes a release member andan energy storage member. The energy storage member has a first positionand a second position. When in the first position, the energy storagemember has a first potential energy. When in the second position theenergy storage member has a second potential energy less than the firstpotential energy. The energy storage member is configured to convert aportion of the first potential energy into kinetic energy when it movesfrom its first position to its second position to move the medicamentcontainer within the housing. The energy storage member has alongitudinal axis offset from a longitudinal axis of the medicamentcontainer. The release member is configured to selectively deploy theenergy storage member from its first position to its second position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a system according to an embodiment ofthe invention.

FIG. 2 is a front view of a system according to an embodiment of theinvention.

FIG. 3 is a side view of a system according to an embodiment of theinvention.

FIG. 4 is a cross-sectional view taken along line A-A of FIG. 3 of asystem according to an embodiment of the invention in a first operativeposition.

FIG. 5 is a cross-sectional view taken along line A-A of FIG. 3 of asystem according to an embodiment of the invention in a second operativeposition.

FIG. 6 is a cross-sectional view taken along line A-A of FIG. 3 of asystem according to an embodiment of the invention in a third operativeposition.

FIG. 7 is a cross-sectional view taken along line A-A of FIG. 3 of asystem according to an embodiment of the invention in a fourth operativeposition.

FIG. 8 is a cross-sectional view taken along line A-A of FIG. 3 of asystem according to an embodiment of the invention in a fifth operativeposition.

FIG. 9 is a cross-sectional view taken along line A-A of FIG. 3 of asystem according to an embodiment of the invention in a sixth operativeposition.

FIG. 10 is a flowchart illustrating a method according to an embodimentof the invention.

FIG. 11 is a perspective view of a system according to an embodiment ofthe invention.

FIG. 12 is a perspective cross-sectional view the system illustrated inFIG. 11 taken along line B-B of FIG. 11.

FIG. 13 is a perspective view of an apparatus according to an embodimentof the invention.

FIG. 14 is a cross-sectional view of a mechanism according to anembodiment of the invention taken along line A-A of FIG. 3.

FIGS. 15 and 16 are schematic illustrations of an auto-injectoraccording to an embodiment of the invention in a first configuration anda second configuration, respectively.

FIG. 17 is a perspective view of an auto-injector according to anembodiment of the invention.

FIG. 18 is a perspective view of the auto-injector illustrated in FIG.17 in a first configuration, with at least a portion of theauto-injector illustrated in phantom lines for ease of reference.

FIG. 19 is a front view of the auto-injector illustrated in FIGS. 17 and18 in a first configuration.

FIG. 20 is a perspective view of the auto-injector illustrated in FIG.17 showing an assembly according to an embodiment of the invention beingremoved.

FIG. 21 is a front view of the auto-injector illustrated in FIG. 17showing a member according to an embodiment of the invention beingremoved.

FIG. 22 is an exploded perspective view of the a portion of theauto-injector illustrated in FIG. 20.

FIG. 23 is a cross-sectional view of a component illustrated in FIG. 21.

FIG. 24 is a perspective view of a component illustrated in FIG. 21.

FIG. 25 is a perspective view of a member of the auto-injectorillustrated in FIG. 21.

FIG. 26 is a perspective view of a portion of the auto-injectorillustrated in FIGS. 17 and 21.

FIG. 27 is a perspective view of a portion of the auto-injectorillustrated in FIGS. 17 and 26.

FIG. 28 is a partially exploded perspective view of a base of theauto-injector illustrated in FIG. 26.

FIG. 29 is an exploded perspective view of a portion of theauto-injector shown in FIG. 21.

FIG. 30 is a front view of a component of the auto-injector shown inFIG. 29.

FIG. 31 is a front view of the auto-injector illustrated in FIG. 19 in asecond configuration.

FIG. 32 is a perspective view of a portion of the auto-injector shown inFIG. 31.

FIGS. 33 and 34 are perspective views of a portion of the auto-injectorshown in FIG. 32.

FIG. 35 is a top view of the housing of the auto-injector shown in FIG.31.

FIG. 36 is a cross-sectional view of the housing taken along line 36-36in FIG. 35.

FIG. 37 is front view of the auto-injector illustrated in FIGS. 19 and31 in a third configuration.

FIG. 38 is a front view of the portion of the auto-injector labeled as38 in FIG. 37.

FIG. 39 is a perspective view of a portion of the auto-injector shown inFIG. 37.

FIG. 40 is a cross-sectional view of a portion of the auto-injector asshown in FIG. 37.

FIG. 41 is a perspective view of a portion of the auto-injector as shownin FIG. 37.

FIG. 42 is an exploded perspective view of a portion the auto-injectoras shown in FIG. 37.

FIG. 43 is front view of the auto-injector illustrated in FIGS. 19, 31and 38 in a fourth configuration.

FIG. 44 is a front view of a portion of the auto-injector illustrated inFIGS. 19, 31, 38 and 43 in a fifth configuration.

FIG. 45 is a front view of the auto-injector illustrated in FIGS. 19,31, 38, 43 and 44 in a sixth configuration.

FIG. 46 is a front view of an auto-injector according to an embodimentof the invention.

FIG. 47 is a schematic illustration of an auto-injector according to anembodiment of the invention.

FIG. 48 is a schematic illustration of an auto-injector according to anembodiment of the invention.

FIGS. 49 and 50 are schematic illustrations of an auto-injectoraccording to an embodiment of the invention in a first configuration anda second configuration, respectively.

FIGS. 51 and 52 are schematic illustrations of an auto-injectoraccording to an embodiment of the invention in a first configuration anda second configuration, respectively.

FIGS. 53-55 are schematic illustrations of an auto-injector according toan embodiment of the invention in a first configuration, a secondconfiguration and a third configuration, respectively.

FIGS. 56 and 57 are schematic illustrations of an auto-injectoraccording to an embodiment of the invention in a first configuration anda second configuration, respectively.

FIG. 58 is a front view of a portion of an auto-injector according to anembodiment of the invention.

DETAILED DESCRIPTION

Apparatuses and methods for automatic medicament injection are describedherein. In some embodiments, an apparatus includes a housing, amedicament container disposed within the housing and an actuator. Theactuator is configured to be disposed within the housing and to move themedicament container within the housing. The actuator includes a releasemember and an energy storage member. The energy storage member, whichcan be, for example, a compressed gas container, has a first positionand a second position. When in the first position, the energy storagemember has a first potential energy. When in the second position theenergy storage member has a second potential energy less than the firstpotential energy. The energy storage member is configured to convert aportion of the first potential energy into kinetic energy when movedfrom its first position to its second position to move the medicamentcontainer within the housing. The energy storage member has alongitudinal axis offset from a longitudinal axis of the medicamentcontainer. The release member is configured to selectively deploy theenergy storage member from its first position to its second position.

In some embodiments, an apparatus includes a housing, a needle and anactuator. The needle has a first end and a second end and defines alongitudinal axis. The actuator is configured to be disposed within thehousing and to move the needle between a first needle position and asecond needle position. When in the first needle position, the secondend of the needle is within the housing. When in the second needleposition, the second end of the needle is outside the housing. Theactuator includes a release member and an energy storage member. Theenergy storage member has a first position and a second position. Whenin the first position, the energy storage member has a first potentialenergy. When in the second position the energy storage member has asecond potential energy less than the first potential energy. The energystorage member is configured to convert a portion of the first potentialenergy into kinetic energy when moved from its first position to itssecond position to move the needle between the first needle position andthe second needle position. The energy storage member has a longitudinalaxis offset from the longitudinal axis of the needle. The release memberis configured to selectively deploy the energy storage member from itsfirst position to its second position.

In some embodiments, an apparatus includes a housing, a needle, amedicament container and an actuator. The needle has a first end and asecond end and defines a longitudinal axis. The actuator is configuredto be disposed within the housing and to move the needle between a firstneedle position and a second needle position. When in the first needleposition, the second end of the needle is within the housing. When inthe second needle position, the second end of the needle is outside thehousing. The actuator is further configured to move the medicamentcontainer between a first medicament container position and a secondmedicament container position. When in the first medicament containerposition, a lumen defined by the needle is fluidically isolated from themedicament container. When in the second medicament container position,the first end of the needle is disposed within the medicament containersuch that the lumen is in fluid communication with the medicamentcontainer. The actuator includes a release member and an energy storagemember. The energy storage member has a first position and a secondposition. When in the first position, the energy storage member has afirst potential energy. When in the second position the energy storagemember has a second potential energy less than the first potentialenergy. The energy storage member is configured to convert a portion ofthe first potential energy into kinetic energy when moved from its firstposition to its second position to move the needle between the firstneedle position and the second needle position. The energy storagemember has a longitudinal axis offset from the longitudinal axis of theneedle. The release member is configured to selectively deploy theenergy storage member from the first position to the second position.

In some embodiments, an apparatus includes an actuator disposable withina housing of an auto-injector. The actuator is configured to move amedicament container relative to the housing, and includes a gascontainer, a biasing member and a puncturer. The gas container, which isconfigured to store a compressed gas, is movable between a firstposition and a second position. The biasing member has a retractedconfiguration and an expanded configuration. The biasing member isconfigured to engage the gas container such that when the biasing membermoves from the retracted configuration to the expanded configuration thegas container is moved from the first position to the second position.The puncturer is configured to penetrate a portion of the gas containerwhen the gas container moves to the second position to allow a portionof the compressed gas to be released from the gas container into a gaschamber defined within the housing adjacent the medicament container.

In some embodiments, an apparatus includes a housing having a distal endportion and a proximal end portion, a medicament injector, an energystorage member and a retainer. The medicament injector is disposedwithin the housing and includes a medicament container and a needle. Theenergy storage member, which can be, for example, a gas containerconfigured to contain a pressurized gas, is configured to produce aforce when moved from a first configuration to a second configuration tomove the medicament injector between a first position and a secondposition. The retainer has a first position and a second position. Whenthe retainer is in its first position, the retainer is configured toretain the energy storage member in its first configuration. When theretainer is in its second position, the retainer is configured to allowthe energy storage member to be moved from its first configuration toits second configuration. The retainer is configured to be selectivelymoved from its first position to its second position by manipulating anactuator adjacent the distal end portion of the housing.

FIG. 1 is a perspective view, FIG. 2 is a front view, and FIG. 3 is aside view, of a system 1000 according to the invention, which cancomprise a housing 1100, which, in some embodiments, can comprise ahandheld portion 1800 separated via an actuation guard 1200 from anactuation bar 1300. Actuation guard 1200 can prevent accidentalactivation of system 1000. Housing 1100 can be constructed of a durablematerial, such as stainless steel, aluminum, polycarbonate, etc., toprotect a compressed gas container, medicament, injection apparatusand/or user of system 1000. The injection apparatus can be actuated by afluid pressure, such as pressure provided by the compressed gas, whichupon completion of actuation can escape housing 1100 via gas escapeopening, such as via status indicator 1400.

A status of a system 1000 can be determined via status indicator 1400,which can provide a view, such as via a UV blocking, photo-sensitive,and/or translucent window, into an interior of housing 1100. Viewablethrough the window can be a status of medicament carried by housing1100, a location of a needle and/or injection apparatus for themedicament, and/or an activation status of system 1000. For example, ifthe medicament has aged to the point of discoloration, which aging mightor might not render the medication useless, harmful, etc., statusindicator 1400 can allow that situation to be determined. In someembodiments, gas can escape housing 1100 via status indicator 1400and/or another opening in housing 1100.

Some embodiments of system 1000 can provide a compact medicamentdelivery mechanism that can efficiently and/or rapidly deliver aprescribed dose. The length (L) and width (W) of system 1000 can besimilar to that of a credit card, and the thickness (T) can be less thanone inch. Thus, some embodiments of system 1000 can provide aconveniently carried, easy-to-use, easy to activate drug deliveryapparatus that can require little to no training to safely carry, use,and/or dispose of.

To assist a user in positioning system 1000 in a correct orientation forinjection, system 1000 and/or housing 1100 can provide various tactileclues. For example, a top 1110 of housing 1100 can be rounded, and abottom 1120 of actuation bar 1300 of housing 1100 can be flat. Othertactile clues are also possible, such as bulges, ribs, grooves, gaps,roughened surfaces, indentations, etc.

FIG. 4 is a cross-sectional view taken along line A-A of FIG. 3 of anembodiment of a system 1000 in a first operative position. FIGS. 5, 6,7, 8, and 9 show system 1000 of FIG. 4 in second, third, fourth, fifth,and sixth operative positions, respectively.

System 1000 can comprise a housing 1100, handheld portion 1800,actuation guard 1200, and/or actuation bar 1300. System 1000 cancomprise system actuator 2000, gas reservoirs 3000, medicament actuator4000, medicament storage assembly 5000, medicament carrier 9000, needleassembly 6000, use indicator 7000, and/or gas vent mechanism 8000, etc.

Upon removal, release, rotation, and/or relocation of actuation guard1200, system actuator 2000 can be adapted to rapidly discharge anactuating portion of a contents of a compress gas container. Forexample, system actuator 2000 can comprise a compressed gas container2400, which initially can contain a compressed gas 2500, an actuatingportion of which can be released from container 2400 by penetration of agas port 2600 via a point of a puncturer 2700. Upon removal and/orrelocation of actuation guard 1200, actuation bar 1300 can be movedcloser to and/or in contact with handheld portion 1800. Upon removaland/or relocation of actuation guard 1200, gas container 2400 can bebrought into contact with puncturer 2700 via extension of apre-compressed spring 2300 and/or movement of an actuation stick 2200.Thus, actuation guard 1200 can prevent accidental activation of system1000 and/or unintended discharge of an actuating portion of the contents2500 of gas container 2400.

Once gas port 2600 has been punctured, an actuating portion ofcompressed gas 2500 can escape from container 2400 and flow via gasreservoirs 3000, such as gas channel 3100. The flowing gas can meetand/or apply gas pressure to medicament actuator 4000, which cancomprise a pusher 4100, which can travel within a sleeve 1500 defined bywalls 1520. Sleeve 1500 can be constructed of metal, stainless steel,aluminum, plastic, polycarbonate, etc. Seals 4200, such as o-rings, canresist gas leakage, such as past pusher 4100 and/or out of housing 1100.Thus, pusher 4100 can function as a piston traveling within a cylinder,although it is not necessarily required that the cross-sectional shapeof sleeve 1500 be round.

Medicament actuator 4000 can interface with medicament storage assembly5000. For example, medicament actuator 4000 can comprise a plurality ofplungers 4300, each of which can be capped with a piston 4400 which cansealingly slide and/or move within a corresponding vial 5100 containinga liquid medicament 5200. For example, in response to pressure appliedby an actuating portion of the contents 2500 of compressed gas container2400, pusher 4100 can cause plungers 4300 and/or pistons 4400 tosimultaneously move. The number of corresponding sets of plungers 4300,pistons 4400, and/or vials 5100 can be 2, 3, 4, 5, 6, or more. Pistons4400 can be constructed of a resilient, durable, and/or sealingmaterial, such as a rubber. Each plunger 4300 from the plurality ofplungers can define a longitudinal axis, the longitudinal axes (e.g.,axes 4310, 4320, 4330, 4340) of the plurality of plungers can beparallel, non-coaxial, and/or co-planar.

Each vial 5100 from the plurality of vials can be substantiallycylindrical with a substantially round and/or substantially ellipticalcross-sectional shape. Thus, each vial 5100 can define a longitudinalaxis, the longitudinal axes of the plurality of vials can be parallel,non-coaxial, and/or co-planar. The longitudinal axis of each vial can beco-axial with the longitudinal axis of its corresponding plunger.

Each vial can be capped at one end with a frangible seal 5300, which canbe burst when piston 4400 generates sufficient pressure upon medicament5200, thereby allowing at least a portion of medicament 5200 to flow outof vial 5100 and into medicament carrier 9000. Thus, the plurality ofvials can be fluidly coupleable to the actuating portion of the contents2500 of gas container 2400.

Medicament carrier 9000 can hold each of vials 5100 and can travelwithin sleeve 1500. Medicament carrier 9000 can comprise a plurality ofchannels 9200 adapted to receive medicament 5200 as it exits itsrespective vial 5100, and direct medicament 5200 to a common conduit9300. Medicament carrier 9000 can interface with needle assembly 6000and/or use indicator 7000.

From common conduit 9300, medicament 5200 can enter needle assembly6000, such as into a single needle 6100 via which medicament canapproach needle tip 6200. As medicament actuator 4000 and/or medicamentcarrier 9000 are driven toward actuator bar 1300, needle tip 6200 canpenetrate an end 6400 of needle sheath 6300 and exit actuator bar 1300at needle port 1340.

Referring to FIG. 5, upon movement of actuation bar 1300 closer tohandheld portion 1800, sheath seat 1330 can come in contact with sheathtip 6400, thereby causing sheath 6300 to buckle and/or crumble. Asactuator bar 1300 comes in contact with handheld portion 1800, bar stop1320 can approach medicament carrier stop 9400, while carrier spring1600 is compressed.

Referring to FIG. 6, as at least a portion of contents 2500 of gascontainer 2400 escapes, it can flow through channel 3100. The gas, whichcan still be relatively pressurized, can begin to accumulate behindpusher 4100 to form an expanding gas chamber 3200 and to causemedicament actuator 4000, medicament storage assembly 5000, andmedicament carrier 9000 to slide together within sleeve 1500. Asmedicament actuator 4000, medicament storage assembly 5000, andmedicament carrier 9000 slide closer to actuator bar 1300, spring 1600becomes increasingly compressed between bar stop 1320 and medicamentcarrier stop 9400. As medicament actuator 4000, medicament storageassembly 5000, and medicament carrier 9000 slide closer to actuator bar1300, needle tip 6200 can extend further from actuator bar 1300 andsheath 6300 can become further compressed and/or deformed. At itsultimate extension point, needle tip 6200 can extend from housing 1100from approximately 0.25 millimeters to approximately 20 millimeters,including all values and subranges therebetween, such as up toapproximately 2 millimeters, greater than approximately 5 millimeters,from approximately 5.13 millimeters to approximately 9.98 millimeters,etc.

Referring to FIG. 7, as gas chamber 3200 continues to expand, medicamentcarrier 9000 can be driven until medicament carrier stop 9400 contactsactuator bar stop 1300 thereby resisting further travel of medicamentcarrier 9000. At that point, additional expansion of gas chamber 3200can cause medicament actuator 4000, pusher 4100, plungers 4300, and/orpistons 4400 to initiate travel with respect to medicament storageassembly 5000, thereby generating an expulsion pressure in vials 5100,and/or thereby rupturing frangible seals 5300 and allowing medicament5200 to enter medicament carrier 9000, and begin flowing throughmedicament channels 9200, medicament conduit 9300, needle 6100, and/orout needle tip 6200 and into a patient. Alternatively, frangible seals5300 can be replaced and/or augmented by a frangible seal located at ornear where medicament conduit 9300 couples to needle 6100. Frangibleseals 5300 can be constructed of a thin, taught, resilient, durable,and/or sealing material potentially having a predetermined yieldstrength, such as a rubber, such as chromo butyl rubber, and/or of arelatively brittle material potentially having a predetermined yieldstrength, such as ceramic, certain plastics, such as polystyrene, etc.

As medicament carrier stop 9400 contacts actuator bar stop 1320,medicament carrier hooks 9600 can engage with engagement receivers 7100in use indicator 7000.

Referring to FIG. 8, as gas chamber 3200 continues to expand, medicamentactuator 4000, pusher 4100, plungers 4300, and/or pistons 4400 cancontinue moving until they complete their travel within medicamentstorage assembly 5000, thereby expelling a predetermined dose ofmedicament 5200 from vials 5100, out of needle assembly 6000, externalto housing 1100, and/or into the patient. As gas chamber 3200 reachesits maximum size, medicament actuator 4000, pusher 4100, plungers 4300,and/or pistons 4400 can continue moving until they complete their travelwith respect to medicament carrier 9000, thereby causing gas releaseactuator 9700 to engage with gas relief valve 8200. Engagement of gasrelease actuator 9700 with gas relief valve 8200 can cause gas withingas chamber 3200 to exit gas chamber 3200, discharge away from pistons4400, and/or exhaust from system 1000 and/or housing 1100, such as viastatus indicator 1400 and/or a gas escape port located on housing 1100).

Referring to FIG. 8 and FIG. 9, as sufficient gas is vented from gaschamber 3200, the pressure applied by the gas in gas chamber 3200 candecrease until the force applied by the gas on medicament actuator 4000is less than the force of compressed spring 1600. Thus, spring(s) 1600can begin to expand, thereby moving medicament carrier 9000, vialassembly 5000, and medicament actuator 4000 away from actuator bar 1300and helping to exhaust gas from gas chamber 3200. As medicament carrier9000 moves, use indicator 7000 can travel with it, due to the engagedrelationship of medicament carrier hooks 9600 and engagement receivers7100 and/or engagement catches 7200 in use indicator 7000. As useindicator 7000 moves away from actuation bar 1300, sheath 6300 cantravel with it, thereby creating a gap between sheath tip 6400 andneedle port 1340, and thereby exposing a previously non-visible coloredportion 1350 of actuation bar 1300 and/or providing an indication thatsystem 1000 has been used (and likely substantially exhausted of itsmedicament), thereby discouraging any further attempts to use system1000.

As medicament carrier 9000 moves away from actuator bar 1300, needle6100 can retract into sheath 6300 which un-buckles and/or un-deformstowards its original shape. Eventually, needle 6100 can retractcompletely within the boundaries of housing 1100, thereby tending toprevent accidental needle sticks after the initial injection and/orpotentially reducing and/or eliminating a sharps hazard.

In some embodiments, system actuator 2000 can comprise a fingertriggered, twistable, pivotable, and/or lever-operated mechanism. Forexample, system actuator 2000 can comprise a twistable handle that canscrew into gas port 2600. In some embodiments, system actuator 2000 canbe a finger trigger located on a side of the housing.

FIG. 10 is a flowchart of an embodiment of a method 10000 for operatinga medicament delivery apparatus. At activity 10100, an actuation lockfor the apparatus is released. At activity 10200, an actuating portionof the contents of a compressed gas container are released. At activity10300, via pressure provided by the released gas, a needle is extendedfrom the apparatus. At activity 10400, via pressure provided by thereleased gas, a piston applies pressure to a medicament stored in one ofa plurality of vials. At activity 10500, a frangible seal containing themedicament in the vial is burst. At activity 10600, the medicament flowsfrom the vial, through the needle, and into a patient. At activity10700, once a predetermined dose is expelled and/or injected, the needleis withdrawn from the patient and/or refracted into the pre-use boundsof the apparatus. At activity 10800, the apparatus is rendered unusablefor additional injections and/or indicated as previously utilized.

FIG. 11 is a perspective view of an embodiment of system 1000, showingactuation guard 1200 removed from housing 1100, so that actuation guard1200 no longer separates actuator bar 1300 from handheld portion 1800.Actuation guard 1200 can comprise a grippable portion 1220 that can begripped by a user to pull actuation guard 1200 away from housing 1100,thereby allowing system 1000 to be activated, such as via slappingactuator bar 1300 against a thigh of the user. Actuation guard 1200 cancomprise an actuation stick separator portion 1240, that can keepseparate actuation stick prongs 2240 when actuation guard 1200 isinstalled on housing 1100. Actuation guard 1200 can comprise a guardportion 1260 that can separate actuator bar 1300 from handheld portion1800 when system 1000 is not in use and/or when system 1000 has not beenused.

FIG. 12 is a perspective cross-sectional view taken along line B-B ofFIG. 11, and FIG. 13 is a perspective view of an embodiment of actuationstick 2200. Referring to FIGS. 12 and 13, system 1000 can comprisehousing 1100, actuation bar 1300, and system actuator 2000, which cancomprise prong squeezer 1390, actuation stick 2200, prong retainer 2100,spring 2300, upper spring retainer 2260, gas container 2400, gas port2600, and/or puncturer 2700. When actuation bar 1300 is pressed firmlyagainst a user's body, such as via slapping housing actuation baragainst the user's thigh, buttocks, and/or arm, prong squeezer 1390 canurge prong tips 2220 of prongs 2240 of actuation stick 2200 toward oneanother. Note that prong tips 2200 can have a triangular, wedge,angular, and/or frusto-conical shape. As prongs tips 2220 slide alongthe angled V-groove of prong squeezer 1390, prong catches 2230 cansubstantially lose contact with prong retainer 2100. This can allowcompressed spring 2300 to rapidly urge actuation stick 2200 and gascontainer 2400 toward puncturer 2700, which can penetrate gas port 2600,thereby allowing gas to escape from gas container 2400. Although any ofmany different types of gas containers can be utilized, an example of asuitable gas container can be obtained from Leland Limited, Inc. ofSouth Plainfield, N.J.

FIG. 14 is a cross-sectional view of an embodiment of gas ventingmechanism 8000 of system 1000 taken along line A-A of FIG. 3. System1000 can comprise handheld portion 1800, actuator bar 1300, sleeve 1500.As pistons 4440 near the limit of their travels, medicament 5200 can beexpelled along medicament path 5900, which can extend past frangibleseal 5300, through medicament channels 9200, medicament conduit 9300,and needle 6100, and into the body of a user, such as subcutaneously,intramuscularly, and/or at a depth of from approximately 0.25millimeters to approximately 20 millimeters, including all values andsubranges therebetween, such as up to 2 millimeters, greater than 5millimeters, etc.

As pistons 4440 near the limit of their travels, engagement of gasrelease actuator 9700 with gas relief valve 8200 can cause compressedspring 8300 to move valve arm such that o-ring 8400 is urged away fromits seat 8500. This movement can reveal a passage 8600, via which gascan exit gas chamber 3200 along gas exhaust path 8900, which can extendbetween sleeve inner walls 1520 and outer walls 9100 of medicamentcarrier 9000. Eventually, gas exhaust path 8900 can extend betweenhandheld portion 1800 and actuator bar 1300. Likewise, an alternativeembodiment of valve 8200, made of rubber or any other resilientmaterial, can be placed across seat 8500 to provide a seal that, oncegas release actuator 9700 interacts with valve 8200, allows valve 8200to bend or flap upwards away from seat 8500, causing the gas to escapevia passage 8600.

FIGS. 15 and 16 are schematic illustrations of an auto-injector 2002according to an embodiment of the invention in a first configuration anda second configuration, respectively. The auto-injector 2002 includes ahousing 2110 that contains a medicament container 2262, an energystorage member 2410, a release member 2540 and an injection member 2212.The medicament container 2262, which can be, for example, a pre-filledcartridge, a vial, an ampule or the like, is movably disposed within thehousing 2110. The medicament container 2262 contains a medicament 2268,such as, for example, epinephrine. As illustrated, the medicamentcontainer 2262 can be moved, as indicated by arrow B in FIG. 16, alongits longitudinal axis Lm between a first position (FIG. 15) and a secondposition (FIG. 16). When the medicament container 2262 is in its first(or retracted) position, the medicament container 2262 is spaced apartfrom the injection member 2212. When the medicament container 2262 is inthe second (or advanced) position, the medicament container 2262 isplaced in fluid communication with the injection member 2212. In thismanner, when the medicament container 2262 is in the second (oradvanced) position, the medicament 2268 can be conveyed via theinjection member 2212 from the medicament container 2262 into a body ofa patient. The injection member 2212 can be, for example, a needle, anozzle or the like.

The energy storage member 2410, which can be any suitable device forstoring energy, such as, for example, a spring, a battery, a compressedgas cylinder or the like, is also movably disposed within the housing2110. As shown, the energy storage member 2410 defines a longitudinalaxis Le that is offset from the longitudinal axis Lm of the medicamentcontainer 2262. The energy storage member 2410 can be moved, asindicated by arrow A in FIG. 16, within the housing 2110 along itslongitudinal axis Le between a first position (FIG. 15) and a secondposition (FIG. 16). When the energy storage member 2410 is in its firstposition, the energy storage member 2410 has a first potential energy.When the energy storage member 2410 is in its second position, theenergy storage member 2410 has a second potential energy that is lessthan the first potential energy. When the energy storage member 2410moves from its first position to its second position, it converts atleast a portion of its first potential energy into kinetic energy tomove the medicament container 2262 between its first position and itssecond position.

Said another way, the movement of the energy storage member 2410 fromits first position to its second position results in the production of aforce that acts upon the medicament container 2262 to move themedicament container 2262 between its first position and its secondposition. The non-coaxial relationship between the longitudinal axis Lmof the medicament container 2262 and the longitudinal axis Le of theenergy storage member 2410 allows the medicament container 2262 and theenergy storage member 2410 to be arranged within the housing 2110 in anynumber of different configurations. In this manner, the auto-injector2002 can have any number of different sizes and shapes, such as, forexample, a substantially rectangular shape.

The release member 2540 is disposed within the housing 2110 and isconfigured to selectively deploy the energy storage member 2410 from itsfirst position to its second position. The release member 2540 can beany suitable mechanism for moving the energy storage member 2410, suchas, for example, a mechanical linkage, a spring-loaded rod or the like.In this manner, a user can actuate the auto-injector by manipulating aportion of the release member 2540.

FIG. 17 is a perspective view of an auto-injector 3002 according to anembodiment of the invention in a first configuration. The auto-injector3002 includes a housing 3110 having a proximal end portion 3112 and adistal end portion 3114. The distal end portion 3114 of the housing 3110includes a protrusion 3142 to help a user grasp and retain the housing3110 when using the auto-injector 3002. Said another way, the protrusion3142 is configured to prevent the auto-injector 3002 from slipping fromthe user's grasp during use. A base 3520 is movably coupled to thedistal end portion 3114 of the housing 3110. A needle guard assembly3810 is removably coupled to the base 3520. Similarly, a safety lock3710 is removably coupled to the base 3520. To inject a medicament intothe body, the distal end portion 3114 of the housing is oriented towardsthe user such that the base 3520 is in contact with the portion of thebody where the injection is to be made. The base 3520 is then movedtowards the proximal end 3112 of the housing 3110 to actuate theauto-injector 3002. The housing 3110 also includes a transparent statuswindow 3118 (see FIG. 36) to allow a user to determine the status of theauto-injector 3002 or the medicament contained therein.

FIG. 18 is a perspective view of the auto-injector 3002 showing thehousing 3110 in phantom lines so that the components contained withinthe housing 3110 can be more clearly seen. For clarity, FIG. 18 showsthe auto-injector 3002 without the needle guard assembly 3810 and thesafety lock 3710. Similarly, FIG. 19 is a front view of theauto-injector 3002 showing the housing 3110 in phantom lines. Theauto-injector 3002 includes a medicament injector 3210 and a movablemember 3312 engaged with the medicament injector 3210, each of which aredisposed within the housing 3110. The auto-injector 3002 also includes asystem actuator 3510, a compressed gas container 3412 and a gas releasemechanism 3612.

The medicament injector 3210 includes a carrier 3250 that is movablewithin the housing 3110, a medicament container 3262 and a needle 3212.The medicament container 3262 is coupled to the carrier 3250. The needle3212 is disposed within a needle hub portion 3223 (see FIG. 22) of thecarrier to allow the needle 3212 to be placed in fluid communicationwith the medicament container 3262 during an injection event.

The movable member 3312 includes a proximal end portion 3316 and adistal end portion 3318. The proximal end portion 3316 includes asurface 3322 that, together with the housing 3110, defines a gas chamber3120. Said another way, the surface 3322 defines a portion of a boundaryof the gas chamber 3120. The distal end portion 3318 is disposed withinthe medicament container 3262. In use, the movable member 3312 movestowards the distal end portion 3114 of the housing 3110, as indicated byarrow C, in response to a force produced by a pressurized gas on thesurface 3322 of the movable member 3312. As a result, the movable member3312 and the medicament injector 3250 are moved towards the distal endportion 3114 of the housing 3110, thereby exposing the needle 3212 fromthe housing 3110. The movable member 3312 then continues to move withinthe medicament container 3262 to expel a medicament from the medicamentcontainer 3262 through the needle 3212.

The auto-injector 3002 is actuated by the system actuator 3510, which isconfigured to move the compressed gas container 3412 into contact withthe gas release mechanism 3612. The gas release mechanism 3612 puncturesa portion of the compressed gas container 3412 to release thepressurized gas contained therein into the gas chamber 3120 defined bythe housing 3110.

The system actuator 3510 includes a rod 3540, a spring 3560 and a springretainer 3570. The rod 3540 has a proximal end portion 3542 and a distalend portion 3544. The proximal end portion 3542 of the rod 3540 iscoupled to the compressed gas container 3412. The distal end portion3544 of the rod 3540 is coupled to the spring retainer 3570 by twoprojections 3548, which can be moved inwardly towards each other todecouple the rod 3540 from the spring retainer 3570, as discussed below.

The spring 3560 is disposed about the rod 3540 in a compressed statesuch that the spring 3560 is retained by the proximal end portion 3542of the rod 3540 and the spring retainer 3570. In this manner, the rod3540 is spring-loaded such that when the distal end portion 3544 of therod 3540 is decoupled from the spring retainer 3570, the force of thespring 3560 causes the rod 3540, and therefore the compressed gascontainer 3412, to move proximally as indicated by arrow D and intocontact with the gas release mechanism 3612.

The base 3520 defines an opening 3522 configured to receive a portion ofthe projections 3548 when the base is moved towards the proximal end3112 of the housing 3110, as indicated by arrow E. When the projections3548 are received within the opening 3522, they are moved togethercausing the distal end portion 3544 of the rod 3540 to be released fromthe spring retainer 3570.

As shown in FIGS. 18 and 19, the medicament injector 3210 defines alongitudinal axis Lm that is non-coaxial with the longitudinal axis Ledefined by the compressed gas container 3412. Accordingly, themedicament injector 3210, the compressed gas container 3412 and thesystem actuator 3510 are arranged within the housing 3110 such that thehousing has a substantially rectangular shape. Moreover, the non-coaxialrelationship between the medicament injector 3210 and the compressed gascontainer 3412 allows the auto-injector 3002 to be actuated bymanipulating the base 3520, which is located at the distal end portion3114 of the housing 3110.

As discussed above, the use and actuation of the auto-injector 3002includes several discrete operations. First, the auto-injector 3002 isenabled by removing the needle guard 3810 and the safety lock 3710 (seeFIGS. 20 and 21). Second, the auto-injector 3002 is actuated by movingthe base 3520 proximally towards the housing 3110. Third, when actuated,the compressed gas container 3412 engages the gas release mechanism3612, which causes the pressurized gas to be released into the gaschamber 3120 (see FIG. 31). Fourth, the pressurized gas produces a forcethat causes the movable member 3312 and the medicament injector 3210 tomove distally within the housing 3110 (see FIG. 37). The movement of themedicament injector 3210 causes the needle 3212 to extend from distalend portion 3114 of the housing 3110 and the base 3520. This operationcan be referred to as the “needle insertion” operation. Fifth, when themedicament injector 3210 has completed its movement (i.e., the needleinsertion operation is complete), the movable member 3312 continues tomove the medicament container 3262 distally within the carrier 3250. Thecontinued movement of the medicament container 3262 places the needle3212 in fluid communication with the medicament container 3262, therebyallowing the medicament to be injected (see FIG. 43). Sixth, the forcefrom the pressurized gas causes the movable member 3312 to move withinthe medicament container 3262, thereby expelling the medicament throughthe needle 3212 (see FIG. 44). This operation can be referred to as the“injection operation.” Seventh, upon completion of the injection, thepressurized gas is released from the gas chamber 3120, thereby allowingthe medicament injector 3210 and the movable member 3312 to be movedproximally within the housing. This operation can be referred to as the“retraction operation” (see FIG. 45). A detailed description of thecomponents contained in the auto-injector 3002 and how they cooperate toperform each of these operations is discussed below.

Prior to use, the auto-injector 3002 must first be enabled by firstremoving the needle guard 3810 and then removing the safety lock 3710.As illustrated by arrow G in FIG. 20, the needle guard 3810 is removedby pulling it distally. Similarly, as illustrated by arrow H in FIG. 21,the safety lock 3710 is removed by pulling it substantially normal tothe longitudinal axis Le of the compressed gas container 3412. Saidanother way, the safety lock 3710 is removed by moving it in a directionsubstantially normal to the direction that the needle guard 3810 ismoved. As described in more detail herein, the needle guard 3810 and thesafety lock 3710 are cooperatively arranged to prevent the safety lock3710 from being removed before the needle guard 3810 has been removed.Such an arrangement prevents the auto-injector 3002 from being actuatedwhile the needle guard 3810 is in place.

As illustrated in FIG. 22, the needle guard 3810 includes a sheath 3820and a sheath retainer 3840. The sheath 3820 has a proximal end portion3822 and a distal end portion 3824 and defines an opening 3826configured to receive a portion of the needle 3212 when the needle guard3810 is in a first (or installed) position. The sheath 3820 furtherdefines a recessed portion 3828 within the opening 3826 that engages acorresponding protrusion 3238 defined by an outer surface 3236 of theneedle hub 3223. In this manner, when the needle guard 3810 is in itsfirst position, the sheath 3820 is removably coupled to the needle hub3223. In some embodiments, the recessed portion 3828 and the protrusion3238 form a seal that is resistant to microbial penetration.

The sheath retainer 3840 has a proximal portion 3842 and a distalportion 3844. The proximal portion 3842 of the sheath retainer 3840includes a protrusion 3856 that engages a corresponding recess 3526 inthe base 3520 (see FIG. 28) to removably couple the sheath retainer 3840to the base 3520. The distal portion 3844 of the sheath retainer 3840defines an opening 3846 through which the distal end portion 3824 of thesheath 3820 is disposed. The distal portion 3844 of the sheath retainer3840 includes a series of retaining tabs 3852 that engage the distal endportion 3824 of the sheath 3820 to couple the sheath 3820 to the sheathretainer 3840. In this manner, when the sheath retainer 3840 is moveddistally away from the base 3520 into a second (or removed) position, asshown in FIG. 20, the sheath 3820 is removed from the needle 3412.Moreover, this arrangement allows the sheath 3820 to be disposed aboutthe needle 3412 independently from when the sheath retainer 3840 iscoupled to the sheath 3820. As such, the two-piece construction of theneedle guard provides flexibility during manufacturing. The distalportion 3844 of the sheath retainer 3840 also includes a protrusion 3848to aid the user when grasping the needle guard 3810.

When the needle guard 3810 is in its first position, the sheath retainer3840 is disposed within a recess 3720 defined by one of the extendedportions 3716 of the safety lock 3710 (see FIG. 25). This arrangementprevents the safety lock 3710 from being removed when the needle guard3810 is in its first position, which in turn, prevents the auto-injector3002 from being actuated when the needle guard 3810 is in its firstposition.

The outer surface of the sheath retainer 3840 includes an indicia 3850to instruct the user in operating the auto-injector 3002. As shown inFIG. 21, the indicia 3850 includes a numeral to indicate the order ofoperation and an arrow to indicate the direction in which the needleguard 3810 should be moved. In some embodiments, the indicia 3850 caninclude different colors, detailed instructions or any other suitableindicia to instruct the user. In other embodiments, the indicia 3850 canprotrude from the sheath retainer 3840 to aid the user when grasping theneedle guard 3810.

In some embodiments, the sheath 3820 can be constructed from anysuitable material, such as, for example polypropylene, rubber or anyother elastomer. In some embodiments, the sheath 3820 can be constructedfrom a rigid material to reduce the likelihood of needle sticks duringthe manufacturing process. In other embodiments, the sheath 3820 can beconstructed from a flexible material.

After the needle guard 3810 is removed, the user must then remove thesafety lock 3710, as indicated in FIG. 21. As shown in FIG. 25, thesafety lock 3710 is a U-shaped member having a first end 3712 and asecond end 3714. The second end 3714 of the safety lock 3710 includestwo extended portions 3716, each of which includes an inwardly facingprotrusion 3718. When the safety lock 3710 is in its first (or locked)position, the extended portions 3716 extend around a portion of the base3520 to space the base 3520 apart from the distal end portion 3114 ofthe housing 3110. As shown in FIG. 26, the protrusions 3718 areconfigured engage a portion of the base 3520 to removably couple thesafety lock 3710 in its first position.

One of the extended portions 3716 defines a recess 3720 that receivesthe sheath retainer 3840 when the needle guard 3810 is in its firstposition, as discussed above. Although only one extended portion 3716 isshown as including a recess 3720, in some embodiments both extendedportions 3716 can include a recess 3720 to receive the sheath retainer3840. In other embodiments, the safety lock 3710 can be engaged with theneedle guard 3810 to prevent movement of the safety lock 3710 when theneedle guard 3810 is in place in any suitable manner. For example, insome embodiments, the sheath retainer can include protrusions that arereceived within corresponding openings defined by the safety lock. Inother embodiments, the safety lock can include protrusions that arereceived within corresponding openings defined by the sheath retainer.

The first end 3712 of the safety lock 3710 includes a locking protrusion3722 that extends inwardly. As shown in FIG. 26, when the safety lock3710 is in its first position, the locking protrusion 3722 extendsbetween the projections 3548 of the rod 3540 and obstructs the opening3522 of the base 3520. In this manner, when the safety lock 3710 is inits first position, the base 3520 cannot be moved proximally to allowthe projections 3548 to be received within the opening 3522. Thearrangement of the locking protrusion 3722 also prevents the projections3548 from being moved inwardly towards each other. Accordingly, when thesafety lock 3710 is in its first position, the auto-injector 3002 cannotbe actuated.

The outer surface 3724 of the first end 3712 of the safety lock 3710includes a series of ridges 3726 to allow the user to more easily gripthe safety lock 3710. The outer surface 3724 of the first end 3712 ofthe safety lock 3710 also includes an indicia 3728 to instruct the userin operating the auto-injector 3002. As shown in FIG. 25, the indicia3728 includes a numeral to indicate the order of operation and an arrowto indicate the direction in which the safety lock 3710 should be moved.In some embodiments, the indicia 3728 can include different colors,detailed instructions or any other suitable indicia to instruct theuser. In other embodiments, the indicia 3728 can protrude from thesafety lock 3710 to aid the user when grasping the safety lock 3710.

After being enabled, the auto-injector 3002 can then be actuated bymoving the base 3520 proximally towards the housing 3110, as indicatedby arrow I in FIG. 27. As shown in FIGS. 28 and 36, the base 3520defines two openings 3536 that receive corresponding attachmentprotrusions 3150 disposed on the distal end portion 3114 of the housing3110. In this manner, the movement and/or alignment of the base 3520relative to the housing 3110 is guided by the attachment protrusions3150 and the openings 3536 (see FIG. 36).

Each attachment protrusion 3150 is secured within its correspondingopening 3536 by a lock washer 3534. The lock washers 3534 each define anopening 3535 that receives a portion of the attachment protrusion 3150.The lock washers 3534 are disposed within slots 3533 defined by the base3520 so that the openings 3535 are aligned with the attachmentprotrusions 3150. The openings 3535 are configured to allow the lockwashers 3534 to move proximally relative to the attachment protrusions3150, but to prevent movement of the lock washers 3534 distally relativeto the attachment protrusions 3150. In this manner, when the attachmentprotrusions 3150 are disposed within the openings 3535 of the lockwashers 3534, the base 3520 becomes fixedly coupled to the housing 3110.Moreover, after the base 3520 is moved proximally relative to thehousing 3110, the lock washers 3534 prevent the base 3520 from returningto its initial position. Said another way, the arrangement of the lockwashers 3534 prevents the base 3520 from being “kicked back” after theauto-injector 3002 has been actuated.

The base 3520 also defines a needle opening 3532, a recess 3526 and tworetraction spring pockets 3531. The needle opening 3532 receives aportion of the needle guard 3810 when the needle guard is in its firstposition. Additionally, when the auto-injector is in its thirdconfiguration (see FIG. 37), the needle 3212 extends through the needleopening 3532. As described above, the recess 3526 receives thecorresponding protrusion 3856 on the sheath retainer 3840 to removablycouple the needle guard 3810 to the base 3520. As will be described inmore detail herein, the retraction spring pockets 3531 receive a portionof the refraction springs 3350.

As shown in FIG. 28, the base 3520 includes two opposing taperedsurfaces 3524 that define an opening 3522 configured to receive acorresponding tapered surface 3550 of the projections 3548 when the baseis moved proximally towards the housing 3110. When the projections 3548are received within the tapered opening 3522, they are moved together asindicated by arrows J in FIG. 27. The inward movement of the projections3548 causes the rod 3540 to become disengaged from the spring retainer3570, thereby allowing the rod 3540 to be moved proximally along itslongitudinal axis as the spring 3560 expands. A more detaileddescription of the components included in the system actuator 3510 isprovided below with reference to FIGS. 29 and 30.

The system actuator 3510 includes a rod 3540, a spring 3560 disposedabout the rod 3540 and a spring retainer 3570. As described in moredetail herein, the spring retainer 3570 retains both the spring 3560 andthe rod 3540. The spring retainer 3570 includes a first surface 3572, asecond surface 3574 and a series of outwardly extending engagement tabs3576. The spring retainer 3570 is disposed within the gas containeropening 3124 defined by the housing 3110 (see FIG. 36) such that theengagement tabs 3576 engage the interior surface 3123 of the housing3110 to produce an interference fit. In this manner, the spring retainer3570 is fixedly disposed within the housing 3110.

The rod 3540 has a proximal end portion 3542 and a distal end portion3544. The distal end portion 3544 of the rod 3540 includes twoextensions 3552 disposed apart from each other to define an opening 3554therebetween. Each extension 3552 includes a projection 3548 having atapered surface 3550 and an engagement surface 3549. When the rod 3540is in its first (or engaged) position, the engagement surfaces 3549engage the second surface 3574 of the spring retainer 3570 to preventthe rod 3540 from moving proximally along its longitudinal axis. Asdescribed above, when the base 3520 is moved proximally towards thehousing 3110, the tapered surfaces 3550 of the projections 3548cooperate with the corresponding tapered surfaces 3524 of the base 3520to move the extensions 3552 inwardly towards each other. The inwardmotion of the extensions 3552 causes the engagement surfaces 3549 tobecome disengaged from the second surface 3574 of the spring retainer3570, thereby allowing the rod 3540 to move between its first positionto a second (or actuated) position.

The proximal end portion 3542 of the rod 3540 includes a retentionportion 3545 having a first surface 3547 and a second surface 3546. Thefirst surface 3547 of the retention portion 3545 engages the distalportion 3416 of the compressed gas container 3412. The second surface3546 of the retention portion 3545 engages a proximal end 3562 of thespring 3560. Similarly, the first surface 3572 of the spring retainer3570 engages a distal end 3564 of the spring 3560. In this manner, whenthe rod 3540 is in its first position, the spring 3560 can be compressedbetween the spring retainer 3570 and the retention portion 3545 of therod 3540. Accordingly, when the rod 3540 is disengaged from the springretainer 3570, the force imparted by the spring 3560 on the retentionportion 3545 of the rod 3540 causes the rod 3540 to move proximally intoits second position.

The proximal end portion 3542 of the rod 3540 is coupled to thecompressed gas container 3412 by a connector 3580, which is secured tothe distal end portion 3416 of the compressed gas container 3412 by asecuring member 3588. The connector 3580 includes a proximal end portion3582 and a distal end portion 3584. The distal end portion 3584 of theconnector 3580 is disposed within the opening 3554 defined between theextensions 3552. In this manner, the connector 3580 is retained by theproximal end portion 3542 of the rod 3540. As will be described in moredetail, the distal end portion 3584 of the connector 3580 includeslocking tabs 3587.

The proximal end portion 3582 of the connector 3580 includes engagementportions 3586 that engage the distal end portion 3416 of the compressedgas container 3412. The engagement portions 3586 are coupled to thecompressed gas container 3412 by the securing member 3588, which can be,for example, a shrink wrap, an elastic band or the like. In otherembodiments, the engagement portions 3586 can produce an interferencefit with the compressed gas container 3412, thereby eliminating the needfor a securing member 3588.

Because the rod 3540 is coupled to the compressed gas container 3412,when the rod 3540 is moved from its first (engaged) position to itssecond (actuated) position, the compressed gas container 3412 is movedproximally within the housing 3110 into engagement with the gas releasemechanism 3612. FIG. 31 shows the auto-injector in a secondconfiguration, in which the compressed gas container 3412 is engagedwith the gas release mechanism 3612. When in the second configuration,the compressed gas contained within the compressed gas container 3412 isreleased to actuate the medicament injector 3210. A more detaileddescription of the gas release process is provided below with referenceto FIGS. 32 through 36.

FIG. 32 shows an exploded view of the system actuator 3510, thecompressed gas container 3412 and the gas release mechanism 3612, eachof which are disposed within the gas container opening 3124 defined bythe housing 3110 (see FIG. 36). As shown, the compressed gas container3412, the system actuator 3510 and the gas release mechanism 3612 arearranged substantially coaxial with each other. As previously discussed,when the auto-injector 3002 is actuated, the compressed gas container3412 is moved proximally within the gas container opening 3124 definedby the housing 3110, as indicated by the arrow K in FIG. 32, until theproximal end 3414 of the compressed gas container 3412 engages the gasrelease mechanism 3612.

As shown in FIGS. 33 and 34, the gas release mechanism 3612 includes acap 3630 and a puncturing element 3620 coupled to and disposed withinthe cap 3630. The puncturing element has a proximal end 3622 and adistal end 3624. The distal end 3624 of the puncturing element 3620defines a sharp point 3626 configured to puncture the proximal end 3414of the compressed gas container 3412. The puncturing element 3620defines an opening 3627 extending from its distal end 3624 to itsproximal end 3622.

The cap 3630 has a proximal end 3632, an outer surface 3635 and an innersurface 3636. The inner surface 3636 of the cap 3630 defines an opening3634 that receives the proximal end 3414 of the compressed gas container3412 when the auto-injector 3002 is in its second configuration. Theproximal end 3632 of the cap 3630 defines an opening 3638 therethroughand a channel 3640 in fluid communication with the opening 3638. Theopening 3638 receives the proximal end 3622 of the puncturing element3620 to couple the puncturing element 3620 to the cap 3630. Thepuncturing element 3620 is disposed within the cap 3630 such that whenthe compressed gas container 3412 is moved into the opening 3634, thedistal end 3624 of the puncturing element 3620 punctures the proximalend 3414 of the compressed gas container 3412.

The cap 3630 is disposed within the gas container opening 3124 such thatthe outer surface 3635 of the cap 3630 engages the inner surface 3123 ofthe housing 3110. In some embodiments, the outer surface 3635 of the cap3630 can be sized to produce an interference fit with the inner surface3123 of the housing 3110. In other embodiments, the cap 3630 can befixedly coupled within the gas container opening 3124 using an adhesiveor any other suitable attachment mechanism.

The cap 3630 is oriented within the gas container opening 3124 so thatthe channel 3640 is aligned with and in fluid communication with the gaspassageway 3126 defined by the housing 3110. Moreover, when oriented inthis manner, the protrusion 3642 on the proximal end 3632 of the cap3630 obstructs a portion of the gas passageway 3126, which can bemanufactured as a through-hole, to fluidically isolate the gaspassageway 3126 from an area outside of the housing 3110. After theproximal end 3414 of the compressed gas container 3412 has beenpunctured, pressurized gas flows from the compressed gas container 3412into the gas passageway 3126 through the opening 3627 defined by thepuncturing element 3620 and the channel 3640 defined by the proximal end3632 of the cap 3630.

The inner surface 3636 of the cap 3630 is configured to hermeticallyseal the proximal end 3414 of the compressed gas container 3412 withinthe opening 3638. This arrangement prevents pressurized gas from leakingaround the compressed gas container 3412 to an area outside of thehousing 3110 after the proximal end 3414 of the compressed gas container3412 has been punctured. In some embodiments, the inner surface 3636 issized to produce an interference fit with the compressed gas container3412. In other embodiments, the cap 3630 includes a separate sealingmember, such as, for example, an o-ring, to seal the proximal end 3414of the compressed gas container 3412 within the opening 3638.

After the compressed gas container 3412 is moved into engagement withthe gas release mechanism 3612, the position of the compressed gascontainer 3412 within the gas container opening 3124 is maintained bythe locking tabs 3587 on the connector 3580. As shown in FIG. 29, eachlocking tab 3587 includes a pointed portion that is angled outwardlyfrom the connector 3580. This arrangement allows the connector 3580 tomove proximally within the gas container opening 3124 of the housing3110, but prevents the connector 3580 from moving distally within thegas container opening 3124 of the housing 3110. Said another way, thearrangement of the locking tabs 3587 prevents the compressed gascontainer 3412 from being “kicked back” when exposed to the forceproduced by the pressurized gas as the pressurized gas is released.

As previously discussed, the pressurized gas released from thecompressed gas container 3412 produces a force on the boundary of thegas chamber 3120, including the surface 3322 of the movable member 3312.This force causes the movable member 3312 and the medicament injector3210 move together distally within the housing 3110, as shown by arrowL, placing the auto-injector 3002 in a third configuration, as shown inFIG. 37. When in the third configuration, the distal end 3214 of theneedle 3212 is disposed through the opening 3532 defined by the base3520 to an area outside of the auto-injector 3002. Moreover, as shown inFIG. 38, when the auto-injector 3002 is in the third configuration, theproximal end 3216 of the needle 3212 remains spaced apart from thedistal end 3266 of the medicament container 3210, ensuring that theneedle 3212 remains fluidically isolated from the medicament container3210. In this manner, the needle 3212 can be inserted into a patient asthe auto-injector 3002 moves between its second configuration (FIG. 31)and its third configuration (FIG. 37) without injecting the medicamentuntil after insertion is completed. A more detailed description of themedicament injector 3210 and the movable member 3312 is provided belowwith reference to FIGS. 37 through 42.

As previously described, the medicament injector 3210 includes a carrier3250, a medicament container 3262 and a needle 3212. The carrier 3250has a lower portion 3222 and an upper portion 3252. The lower portion3222 of the carrier 3250 includes a needle hub 3223, which contains theneedle 3212. The lower portion 3222 of the carrier 3250 also defines anopening 3224 configured to receive a distal portion 3266 the medicamentcontainer 3262. As shown in FIG. 39, the needle 3212 is coupled to theneedle hub 3223 such that the proximal end 3216 of the needle 3212 isdisposed within the opening 3224 and the distal end 3214 of the needle3212 extends distally outside of the needle hub 3223.

The inner surface 3228 of the lower portion 3222 defining the opening3224 includes a protrusion 3226. The protrusion 3226 is configured toengage a corresponding recess 3272 defined by a sealing cap 3270disposed at the distal portion 3266 of the medicament container 3262(see FIG. 42) to secure the medicament container 3262 within the opening3224 such that the proximal end 3216 of the needle 3212 is spaced apartfrom the distal end 3266 of the medicament container 3210. Theprotrusion 3226 and the recess 3272 are configured such that theprotrusion 3226 will become disengaged from the recess 3272 when theforce applied exceeds a predetermined value. Said another way, theprotrusion 3226 and the recess 3272 collectively form a removablesnap-fit that allows the medicament container 3262 to be moved withinthe opening 3224 when the force applied to the medicament container 3262exceeds a predetermined value. This arrangement ensures that the needle3212 remains fluidically isolated from the medicament container 3262during the insertion operation.

The outer surface 3236 of the lower portion 3222 includes a protrusion3238. As previously described, the protrusion 3238 is configured toengage a corresponding recess portion 3828 within the opening 3826 ofthe sheath 3820 (see FIG. 23) to removably couple the sheath 3820 to theneedle hub 3223.

The lower portion 3222 of the carrier 3250 also defines two retractionspring pockets 3242 each receiving the proximal end 3352 of a refractionspring 3350. As previously discussed, the distal end 3354 of eachretraction spring 3350 is retained within the retraction spring pockets3531 defined by the base 3520. As shown in FIG. 38, when the carrier3250 moves distally within the housing 3110, the retraction springs 3350are compressed and therefore bias the carrier 3250 towards the proximalportion 3112 of the housing 3110.

The upper portion 3252 of the carrier 3250 defines an opening 3256configured to receive a proximal portion 3264 of the medicamentcontainer 3262 and includes two valve actuators 3254. As described inmore detail herein, the valve actuators 3254 are configured to engage agas relief valve 3328 to allow the pressurized gas contained within thegas chamber 3120 to escape when the injection event is complete.

The upper portion 3252 of the carrier 3250 defines four gas reliefpassageways 3258. Similarly, the lower portion 3222 of the carrier 3250defines four gas relief passageways 3244. When the pressurized gas isreleased from the gas chamber 3120, the gas relief passageways 3258,3244 provide a fluid path to allow the pressurized gas to flow from thegas chamber 3120 to an area outside of the housing 3110.

As described above, the movable member 3312 includes a proximal endportion 3316 and a distal end portion 3318. The distal end portion 3318includes a piston 3324 disposed within the proximal portion 3264 of themedicament container 3262, such that the piston engages a plunger 3284contained within the medicament container 3262, as shown in FIG. 42.

The proximal end portion 3316 includes a surface 3322 that defines aportion of a boundary of the gas chamber 3120. As shown in FIG. 41, theproximal end portion 3316 defines two openings 3326 therethrough, eachof which are in fluid communication between the gas chamber 3120 and theinterior of the housing 3110 outside the gas chamber 3120. The proximalend portion 3316 further defines a slot 3330 that receives a gas reliefvalve 3328, which can be, for example, a flexible rubber member. The gasrelief valve 3328 is positioned within the slot 3330 and adjacent theopenings 3326 to selectively allow fluid communication between the gaschamber 3120 and the area outside the gas chamber 3120 through theopenings 3326. The operation of the gas relief valve 3328 is discussedin more detail herein.

The proximal end portion 3316 of the movable member 3312 also includes aseal 3314 that engages a portion the inner surface 3122 of the housing3110 (see FIG. 36) to fluidically isolate the gas chamber 3120. Althoughthe seal 3314 is shown as being an o-ring seal, in some embodiments, theseal need not be a separate component, but can rather be a portion ofthe proximal end portion 3316 of the movable member 3312.

When the needle insertion operation is completed, the lower portion 3222of the carrier 3250 engages the base 3520, preventing further distalmovement of the carrier 3250 within the housing. Because the distalmotion of the carrier 3250 is opposed, the force exerted by thepressurized gas on the surface 3322 of the movable member 3312 increasesuntil the protrusion 3226 of the lower portion 3222 of the carrier 3250and the recess 3272 defined by sealing cap 3270 of the medicamentcontainer 3262 become disengaged. Accordingly, the medicament container3262 to moves distally relative to the carrier 3250, placing theauto-injector 3002 in a fourth configuration, as shown in FIG. 43. Whenmoving between the third configuration (FIG. 38) and the fourthconfiguration (FIG. 43), the proximal end 3216 of the needle 3212pierces the sealing cap 3270 and the liner 3271 disposed at the distalportion 3266 of the medicament container 3262. As such, when in thefourth configuration, the proximal end 3216 of the needle 3212 is influid communication with the medicament container 3262, thereby allowingthe medicament to be injected.

Once the needle 3212 is in fluid communication with the medicamentcontainer 3262, the force from the pressurized gas causes the piston3324 of the movable member 3312 to move the plunger 3284 within themedicament container 3262, as shown by arrow M, thereby expelling themedicament through the needle 3212. The piston 3324 and the plunger 3284move a predetermined distance within the medicament container 3262,placing the auto-injector 3002 in a fifth configuration, as shown inFIG. 44. When the auto-injector 3002 is in the fifth configuration, theinjection of medicament is complete.

When the auto-injector 3002 is in its fifth configuration, proximalportion 3316 of the movable member 3312 is in contact with the upperportion 3252 of the carrier 3250, thereby preventing further movement ofthe piston 3324 within the medicament container 3262. In this manner,the distance through which the piston 3324 travels, and therefore theamount of medicament injected, can be controlled.

Additionally, when the auto-injector 3002 is in its fifth configuration,the valve actuators 3254 are disposed within the openings 3326 such thatthe valve actuators 3254 displace the gas relief valve 3328.Accordingly, the pressurized gas contained within the gas chamber 3120can flow from the gas chamber 3120 to the area within the housing 3310outside of the gas chamber 3310. As previously discussed, the gas reliefpassageways 3258, 3244 provide a fluid path to allow the pressurized gasto flow from the gas chamber 3120, through the opening 3532 defined bythe base 3520 and to an area outside of the housing 3110.

When the pressurized gas flows out of the gas chamber 3120, the pressureexerted on the surface 3322 of the movable member 3312 decreases.Accordingly, the force exerted by the refraction springs 3350 issufficient to move the medicament injector 3210 and the movable member3312 proximally within the housing 3110, as shown by arrow N, into asixth (or retracted) configuration as shown in FIG. 45. Because themedicament injector 3210 and the movable member 3312 move together, thevalve actuators 3254 remain disposed within the openings 3326 as theauto-injector 3002 moves into the sixth configuration. In this manner,the gas relief valve 3328 remains displaced and the openings 3326 remainin fluid communication with the gas chamber 3120 and the area within thehousing 3310 outside of the gas chamber 3310 independent of the positionof the movable member 3312. Such an arrangement ensures that all of thepressurized gas flows out of the gas chamber 3120, thereby ensuring thatthe medicament injector 3210 and the movable member 3312 return to thesixth configuration and do not oscillate between the sixth configurationand the fifth configuration, which could lead to the needle 3212 notbeing fully retracted into the housing 3110.

Although the auto-injector 3002 has been shown and described having ahousing 3110 having a substantially rectangular shape, in someembodiments, an auto-injector can have a housing having any shape. Insome embodiments, for example, an auto-injector can have a substantiallycylindrical shape. In other embodiments, for example, the auto-injectorcan have an irregular and/or asymmetrical shape.

Although the auto-injector 3002 has been shown and described asincluding a protrusion 3142 disposed at the distal end portion 3114 ofthe housing 3110 to help a user grasp and retain the housing 3110, insome embodiments, a protrusion can be disposed anywhere along thehousing. In other embodiments, a protrusion can symmetrically surroundthe distal portion of the housing. In yet other embodiments, the housingof an auto-injector can include a gripping portion configured to help auser grasp and retain the housing. The gripping portion can include, forexample, a textured surface, a contoured surface, a surface having anadhesive that forms a tacky surface to adhere to the user's hand or thelike. For example, FIG. 46 shows an auto-injector 4002 according to anembodiment of the invention having a housing 4110. The housing 4110includes a proximal end portion 4112, a distal end portion 4114 and agripping portion 4140. The distal end portion 4114 of the housing 4110includes a protrusion 4142 to prevent the user's hand from slipping offof the distal end portion 4114 of the housing 4110 when using theauto-injector 4002. Similarly, the gripping portion 4140 includes aseries of contours 4144 that engage the user's fingers to help the usergrasp and retain the housing 4110 when the auto-injector 4002 is in use.

The distal end portion 4114 of the housing 4110 also includes twoalignment marks 4146 to guide the user when placing the auto-injector4002 against the body. Although the alignment marks 4146 are shown asmarkings on the housing 4110, in other embodiments, the alignment markscan include protrusions, openings or the like.

Certain components of the auto-injector 3002 are shown and described asbeing coupled together via protrusions and mating recesses. Theprotrusions and/or recesses can be disposed on any of the components tobe coupled together and need not be limited to only a certain component.For example, the base 3520 is shown as defining two openings 3536 thatreceive corresponding attachment protrusions 3150 on the distal endportion 3114 of the housing 3110. In some embodiments, however, theprotrusions can be disposed on the base and the mating recesses can bedefined by the distal end portion of the housing. In other embodiments,two or more components can be coupled together in any suitable way,which need not include protrusions and mating recesses. For example, insome embodiments, two or more components can be coupled together viamating shoulders, clips, adhesive and the like.

Similarly, although certain components of the auto-injector 3002 areshown and described as being constructed from multiple separatecomponents, in some embodiments, such components can be monolithicallyconstructed. For example, the carrier 3250 is shown and described asincluding an upper portion 3252 and a lower portion 3222 that areconstructed separately and then coupled together. In other embodiments,a carrier can be constructed monolithically.

Although the base 3520 of the auto-injector 3002 has been shown anddescribed covering almost the entire distal end portion 3114 of thehousing 3110, in some embodiments, a base configured to actuate theauto-injector can be disposed about only a portion of the distal end ofthe housing. For example, in some embodiments, an auto-injector caninclude a button extending from the distal end portion of the housingconfigured to engage and release the system actuator.

Although the rod 3540 is shown and described as being an elongatedmember that is released by being elastically deformed, in someembodiments, a rod can be of any suitable shape and in any suitableorientation within the housing. Moreover, in some embodiments, a rod canbe released by being plastically deformed. For example, in someembodiments, a rod can be disposed along an axis that is offset from thelongitudinal axis of the energy storage member. In some embodiments, therod can be configured to break upon actuation.

Although the gas release mechanism 3612 is shown and described asincluding a puncturing element 3620 to puncture a portion of thecompressed gas container 3262, the gas release mechanism 3612 need notinclude a puncturing element 3620. For example, in some embodiments, thegas release mechanism can include an actuator configured to actuate avalve that controls the flow of gas out of the compressed gas container.For example, in some embodiments, a compressed gas container can includea spring loaded check ball and the gas release mechanism can include anactuator configured to engage and depress the check ball to releasepressurized gas from the compressed gas container.

Although the distance through which the piston 3324 travels, andtherefore the amount of medicament injected, is shown and described asbeing controlled by configuring the movable member 3312 such that it isin contact with the upper portion 3252 of the carrier 3250 when theauto-injector 3002 is in its fifth configuration, in other embodiments,any suitable method of controlling the piston travel can be employed.For example, in some embodiments, piston travel can be limited byincluding a protrusion within the medicament container, such as a neckedportion, that limits the motion of the piston within the medicamentcontainer. In other embodiments, the housing can include a protrusion tolimit the motion of the movable member. In yet other embodiments, thevalve actuator can be configured to actuate the gas relief valve whenthe piston has moved a predetermined distance within the medicamentcontainer. In yet other embodiments, a combination of each of the abovemethods for controlling the piston travel can be employed.

Although the auto-injector 3002 is shown and described as having sixdifferent configurations that are different from each other, in someembodiments, certain configuration of an auto-injector can be the sameas another configuration. For example, in some embodiments, a“pre-actuation configuration can be the same as a “retracted”configuration. In other embodiments, any of the functions describedabove can be accomplished when an auto-injector is moved between anynumber of different configurations.

Although the auto-injector 3002 is shown and described as including acompressed gas cylinder 3412, in other embodiments an auto-injector caninclude any suitable energy storage member. For example, in someembodiments, an auto-injector can include a mechanical energy storagemember, such as a spring, an electrical energy storage member, such as abattery or a capacitor, a chemical energy storage member, such as acontainer containing two substances that can react to produce energy, amagnetic energy storage member or the like. Similarly, although theauto-injector 3002 is shown and described as including a gas releasemechanism 3612, in other embodiments an auto-injector can include anysuitable energy release mechanism. Such energy release mechanism caninclude, for example, an electrical circuit, a mechanical springretainer, a fluid control valve or the like.

For example, FIG. 47 shows a schematic illustration of an auto-injector5002 that includes a mechanical energy storage member 5410. Theauto-injector 5002 includes a housing 5110 that contains a medicamentcontainer 5262, an energy storage member 5410, a release member 5540.The medicament container 5262 is movably disposed within the housing5110 and includes a needle 5212 through which a medicament 5268 can beinjected. As illustrated, the medicament container 5262 can be movedalong its longitudinal axis Lm between a first position (FIG. 47) and asecond position (not shown), in which the needle 5212 extends from thehousing 5110.

The energy storage member 5410 includes a spring 5420 that is disposedabout a rod 5422. The rod 5422 has a proximal end 5424 and a distal end5426. The proximal end 5424 of the rod 5422 includes a plunger 5428 thatretains the spring 5420 such that the spring 5420 can be compressed whenthe auto-injector 5002 is in a first configuration. The plunger is alsodisposed within a working fluid chamber 5430. The working fluid chamber5430 can be, for example, a hydraulic cylinder filled with a hydraulicfluid. The distal end 5426 of the rod 5422 engages the release member5540, as discussed below.

In use, the spring 5420 can be moved within the housing 5110 along itslongitudinal axis Le between a first position and a second position.When the spring 5420 moves between its first position to its secondposition, the plunger 5428 moves proximally within the working fluidchamber 5430, causing the working fluid 5431 to be forced through avalve 5434 and into contact with the medicament container 5262. Throughthe kinetic energy produced by the spring 5420, the working fluid 5431produces a force that acts upon the medicament container 5262 to movethe medicament container 5262 between its first position and its secondposition.

The arrangement of a mechanical energy storage member, such as a spring,and a fluidic circuit allows the direction and/or magnitude of the forceproduced by the energy storage member to be changed. In this manner, asshown in FIG. 47, the longitudinal axis Le of the energy storage membercan be offset from the longitudinal axis Lm of the medicament container5262, thereby allowing the medicament container 5262 and the energystorage member 5410 to be arranged within the housing 5110 in any numberof different configurations.

The release member 5540 is disposed adjacent a distal end portion 5114of the housing 5110 and is configured to selectively deploy the spring5420 from its first position to its second position. The release member5540 can be any suitable mechanism of the types described above formoving the spring 5420. In this manner, a user can actuate theauto-injector by manipulating the distal end portion 5114 of the housing5110.

FIG. 48 shows a schematic illustration of an auto-injector 6002 thatincludes an electrical energy storage member 6410, such as, for examplea battery. The auto-injector 6002 includes a housing 6110 that containsa medicament container 6262, an energy storage member 6410, a systemactuator 6510 and an energy release mechanism 6610. The medicamentcontainer 6262 is movably disposed within the housing 6110 and includesa needle 6212 through which a medicament 6268 can be injected. Asillustrated, the medicament container 6262 can be moved along itslongitudinal axis Lm between a first position (FIG. 48) and a secondposition (not shown), in which the needle 6212 extends from the housing6110.

The energy storage member 6410 is also movably disposed within thehousing 6110 along its longitudinal axis Le, which is offset from thelongitudinal axis Lm of the medicament container 6262. When the energystorage member 6410 is in its first position (FIG. 48), it is spacedapart from the electrical contact 6650 of the energy release mechanism6610. When the energy storage member 6410 is in its second position, itis in contact with the electrical contact 6650, thereby allowing currentto flow from the energy storage member 6410 to an actuator 6654 via acircuit 6652. The actuator 6654 converts the electrical energy into aforce that acts upon the medicament container 6262 to move themedicament container 6262 between its first position and its secondposition.

The system actuator 6510 includes a release member 6540 coupled to theenergy storage member 6410, a spring 6560 and an actuator button 6520.The spring 6560 is disposed about the release member 6540 in acompressed configuration. The release member 6540 is removably coupledto the actuator button 6520, which is disposed at the distal end of thehousing 6110. When the actuator button 6520 is manipulated, the releasemember 6540 is de-coupled from the actuator button 6520, therebyallowing the force from the spring 6560 to move the release member 6540.In this manner, the energy storage member 6410 is moved proximallywithin the housing 6110 into its second configuration. In someembodiments, the components included in the system actuator 6510 can beelectrically coupled to the energy storage member 6410.

Although the auto-injectors shown and described include a medicamentcontainer and an energy storage member that are substantially parallel,in some embodiments, the medicament container and the energy storagemember can be angularly offset from each other. For example, FIGS. 49and 50 are schematic illustrations of an auto-injector 7002 in a firstconfiguration and a second configuration, respectively. Similar to theauto-injectors described above, the auto-injector 7002 includes ahousing 7110 that contains a medicament container 7262, an energystorage member 7410, a release member 7540 and an energy releasemechanism 7610. The medicament container 7262, which includes a needle7212, is disposed within the housing such that it can be moved along itslongitudinal axis Lm as indicated by arrow P between a first position(FIG. 49) and a second position (FIG. 50).

The energy storage member 7410 is also movably disposed within thehousing 7110 along its longitudinal axis Le, as shown by arrow Q. Asshown, the longitudinal axis Le is substantially perpendicular to thelongitudinal axis Lm of the medicament container 7262. When the energystorage member 7410 is in its first position (FIG. 49), it is spacedapart from the energy release mechanism 7610. When the energy storagemember 7410 is in its second position (FIG. 50), it is in contact withthe energy release mechanism 7610, thereby releasing energy to produce aforce on the medicament container 7262 in a manner as described above.

As described above, the release member 7540 can be any suitablemechanism configured to selectively deploy the energy storage member7410 from its first position to its second position.

Although the auto-injectors shown and described above include amedicament container configured to move within the housing, in someembodiments, an auto-injector can be configured to move a needle withina stationary medicament container. For example, FIGS. 51 and 52 areschematic illustrations of an auto-injector 8002 in a firstconfiguration and a second configuration, respectively. Theauto-injector 8002 includes a housing 8110 that contains a medicamentcontainer 8262, a movable member 8312, an energy storage member 8410, anenergy release mechanism 8610 and a release member 8540. The medicamentcontainer 8262 is fixedly disposed within the housing and defines alongitudinal axis Lm.

The movable member 8312 includes a proximal end 8316 and a distal end8318. The distal end 8318 of the movable member 8312 is disposed withinand movable within the medicament container 8262 along the longitudinalaxis Lm, as shown by the arrow R. A needle 8212 is coupled to the distalend 8318 of the movable member 8312.

The energy storage member 8410 is also movably disposed within thehousing 8110 along its longitudinal axis Le, as shown by arrow S. Asshown, the longitudinal axis Le is offset from the longitudinal axis Lmof the medicament container 8262. When the energy storage member 8410 isin its first position (FIG. 51), it is spaced apart from the energyrelease mechanism 8610. When the energy storage member 8410 is in itssecond position (FIG. 52), it is in contact with the energy releasemechanism 8610, thereby producing a force on the proximal end 8316 ofthe movable member 8312. The force causes the movable member 8312 to bemoved within the medicament container 8262. In this manner, the needle8212 is extended through the housing 8110 as the medicament is beinginjected.

As described above, the release member 8540 can be any suitablemechanism configured to selectively deploy the energy storage member8410 from its first position to its second position.

Although the auto-injector 3002 is shown and described as including acompressed gas container 3412 disposed non-coaxially with a medicamentcontainer 3262, in some embodiments, an auto-injector can include acompressed gas container that is coaxial with a medicament container.For example, FIGS. 53-55 are schematic illustrations of an auto-injector9002 in a first configuration, a second configuration, and a thirdconfiguration, respectively. The auto-injector 9002 includes a housing9110 that contains a medicament container 9262, a movable member 9312, acompressed gas container 9412 and a puncturer 9612. The medicamentcontainer 9262 is movably disposed within the housing 9110 and includesa needle 9212 through which a medicament 9268 can be injected. Asillustrated, the medicament container 9262 can be moved along itslongitudinal axis Lm between the first configuration (FIG. 53) and thesecond configuration (FIG. 54).

The compressed gas container 9412 is also movably disposed within thehousing 9110 along its longitudinal axis Le, which is coaxial with thelongitudinal axis Lm of the medicament container 9262. A biasing member9560, such as, for example, a spring, is engaged with the compressed gascontainer 9412 to bias the compressed gas container 9412 distallytowards the puncturer 9612. As shown in FIG. 53, when the auto-injector9002 is in the first configuration, a retainer 9540 retains thecompressed gas container 9412 in the proximal portion 9112 of thehousing spaced apart from the puncturer 9612.

The movable member 9312 includes a proximal end portion 9316 and adistal end portion 9318. The proximal end portion 9316 includes asurface 9322 that, together with the housing 9110, defines a gas chamber9120. The distal end portion 9318 is disposed within the medicamentcontainer 9262. The movable member 9312 is configured to move themedicament container 9262 within the housing 9110 and inject themedicament 9268.

In use, the auto-injector 9002 is actuated by manipulating the proximalportion 9112 of the housing 9110 to move the retainer 9540, therebyallowing the compressed gas container 9412 to be moved distally until itengages the puncturer 9612, as shown in FIG. 54. As described above, thepuncturer 9612 punctures a portion of the compressed gas container 9412thereby releasing the pressurized gas contained therein into the gaschamber 9120. The pressurized gas produces a force on the movable member9312, which causes the movable member 9312 and the medicament container9262 to move distally into the second configuration, as shown by thearrow T in FIG. 54. When in the second configuration, the needle 9212 isextended outside of the housing 9110. The movable member 9312 thencontinues to move distally within the medicament container 9262, asshown by the arrow U in FIG. 55. In this manner, the medicament isinjected through the needle 9212.

Although the auto-injectors are shown and described as being actuatedfrom the distal end and including an energy storage member 3412 disposednon-coaxially with a medicament container 3262, in some embodiments, anauto-injector can be actuated from its distal end and include an energystorage member that is coaxial with a medicament container. For example,FIGS. 56 and 57 are schematic illustrations of an auto-injector 10002 ina first and a second configuration, respectively. The auto-injector10002 includes a housing 10110 that contains a medicament container10262, an energy storage member 10410 and a system actuator 10510.

The medicament container 10262 defines a longitudinal axis Lm that iscoaxial with a longitudinal axis of the energy storage member 10410. Themedicament container 10262 includes a needle 10212 through which amedicament can be injected. The medicament container 10262 is movablewithin the housing along its longitudinal axis Lm between a firstposition (FIGS. 56 and 57) and a second position (not shown), in whichthe needle 10212 extends outside of the housing 10110. As describedabove, the medicament container 10262 is moved by a force produced bythe energy storage member 10410.

The energy storage member 10410 is also movably disposed within thehousing 10110 along its longitudinal axis Le, as shown by arrow V inFIG. 57. When the energy storage member 10410 moves between a firstposition (FIG. 56) and a second position (FIG. 57), it produces a forceon the medicament container 10262.

The system actuator 10510 includes a release member 10540 and anactuator button 10520. The release member 10540 is configured toselectively deploy the energy storage member 10410 from its firstposition to its second position. The release member 10540 can be, forexample, a spring-loaded rod, a retainer or the like. The actuatorbutton 10520 is coupled to the release member 10540 such that when theactuator button 10520 is manipulated, the release member 10540 candeploy the energy storage member 10410 from its first position to itssecond position. A portion of the actuator button 10520 extends outsideof the distal end portion 10114 of the housing 10110 such that the usercan actuate the auto-injector 10002 by manipulating the distal endportion 10114 of the housing 10110.

FIG. 58 shows a portion of a distally actuated system actuator 11510according to an embodiment of the invention. Similar to the systemactuators shown and described above, the system actuator 11510 isconfigured to selectively move an energy storage member (not shown) intocontact with an energy release mechanism (not shown). The systemactuator 11510 includes a rod 11540, a spring 11560 and a springretainer 11570. A proximal portion 11542 of the rod 11540 is coupled tothe spring retainer 11570 by two projections 11548, which can be movedinwardly towards each other to decouple the rod 11540 from the springretainer 11570, as previously discussed.

The spring 11560 is disposed about the rod 11540 in a compressed statesuch that the spring 11560 is retained by a distal end portion (notshown) of the rod 11540 and the spring retainer 11570. In this manner,the rod 11540 is spring-loaded, similar to the rod 3540 discussed above.

The system actuator 11510 also includes an actuator button 11520 that iscoupled via a flexible member 11525 to a pair of pivoting members 11523.A portion of the actuator button 11520 extends outside of the distal endportion of the housing (not shown). In use, the user can actuate theauto-injector by manipulating the distal end portion of the housing, forexample, by pressing the actuator button 11520 inwardly as indicated bythe arrow W. The inward movement of the actuator button 11520 causes theflexible member 11525, which can be, for example, a thin cable, to moveas indicated by the arrow X. The movement of the flexible member 11525causes the pivoting members 11523 pivot as indicated by the arrows Y,which then causes the projections 11548 to move together, therebyreleasing the rod 11540 from the spring retainer 11570.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods described above indicate certainevents occurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments where appropriate. For example, in some embodiments, anauto-injector can include a fluidic circuit to change the directionand/or magnitude of the force produced by the energy storage member anda fluid relief valve to relieve the pressure within the fluidic circuitto assist in the retraction of the needle.

1. An apparatus, comprising: a housing defining a first cavity and asecond cavity, a longitudinal axis defined by the first cavity offsetfrom a longitudinal axis defined by the second cavity, a distal endportion of the housing defining a first opening in fluid communicationwith the first cavity and a second opening in fluid communication withthe second cavity; a medicament injector movably disposed within thefirst cavity, the medicament injector including a medicament containerand a needle; an energy storage member disposed within second cavity,the energy storage member configured to produce a force to move themedicament injector to an injection position in which a portion of theneedle is disposed through the first opening; and an actuation memberconfigured to actuate the energy storage member when the actuationmember is moved from a first position to a second position, a firstportion of the actuation member disposed within the second cavity whenthe actuation member is in the first position, a second portion of theactuation member disposed through the second opening when the actuationmember is in the first position.
 2. The apparatus of claim 1, whereinthe actuation member is a first actuation member, the second portion ofthe first actuation member is a retention portion configured to engagethe distal end portion of the housing to limit movement of the firstactuation member, the apparatus further comprising: a second actuationmember coupled to the distal end portion of the housing, a portion ofthe second actuation member configured to disengage the retentionportion from the distal end portion of the housing when the secondactuation member is moved relative to the distal end portion of thehousing.
 3. The apparatus of claim 1, further comprising: a safety lockmovably coupled to the distal end portion of the housing, the safetylock including a protrusion configured to engage the second portion ofthe actuation member to limit movement of the actuation member.
 4. Theapparatus of claim 1, further comprising: a safety lock movably coupledto the distal end portion of the housing, the safety lock including aprotrusion configured to engage the second portion of the actuationmember to limit movement of the actuation member; and a needle guardhaving a first portion and a second portion, the first portion of theneedle guard configured to be disposed through the first opening andabout the needle, the second portion of the needle guard configured toengage the safety lock.
 5. The apparatus of claim 1, wherein the secondportion of the actuation member is configured to contact the energystorage member when the actuation member is in the second position. 6.The apparatus of claim 1, wherein: the actuation member is configured tomove within the housing in a first direction when moving from the firstposition to the second position; and the medicament injector isconfigured to move in a second direction opposite the first directionwhen the medicament injector is moving toward the injection position. 7.The apparatus of claim 1, further comprising: a biasing member disposedwithin the second cavity, the biasing member configured to urge theactuation member towards the second position.
 8. The apparatus of claim1, wherein the energy storage member is a gas container configured toproduce the force when a pressurized gas is released from the gascontainer.
 9. The apparatus of claim 1, wherein the energy storagemember is a gas container configured to produce the force when apressurized gas is released from the gas container, the apparatusfurther comprising: a seal disposed within the second cavity, the sealconfigured to fluidically isolate a proximal end portion of the secondcavity from the second opening.
 10. The apparatus of claim 1, whereinthe energy storage member is a gas container configured to produce theforce when a pressurized gas is released from the gas container, theapparatus further comprising: a puncturer having a portion disposedapart from the gas container when the actuation member is in the firstposition, the portion being disposed within the gas container when theactuation member is in the second position.
 11. An apparatus,comprising: a housing defining a first cavity and a second cavity, alongitudinal axis defined by the first cavity offset from a longitudinalaxis defined by the second cavity; a medicament injector movablydisposed within the first cavity, the medicament injector including amedicament container and a needle; an energy storage member disposedwithin second cavity, the energy storage member configured to produce aforce to move the medicament injector in a first direction within thefirst cavity to an injection position in which a portion of the needleis disposed outside of the housing; and an actuation member configuredto actuate the energy storage member when the actuation member is movedin a second direction within the second cavity from a first position toa second position.
 12. The apparatus of claim 11, wherein: a distal endportion of the housing defines an opening in fluid communication withthe second cavity; and a first portion of the actuation member isdisposed within the second cavity when the actuation member is in thefirst position, a second portion of the actuation member is disposedthrough the opening when the actuation member is in the first position.13. The apparatus of claim 11, wherein the actuation member is a firstactuation member, the first actuation member including a retentionportion configured to engage a distal end portion of the housing tolimit movement of the first actuation member, the apparatus furthercomprising: a second actuation member coupled to the distal end portionof the housing, a portion of the second actuation member configured todisengage the retention portion from the distal end portion of thehousing when the second actuation member is moved relative to the distalend portion of the housing.
 14. The apparatus of claim 11, wherein adistal end portion of the housing defines an opening in fluidcommunication with the second cavity, a retention portion of theactuation member is disposed through the opening when the actuationmember is in the first position, the apparatus further comprising: asafety lock movably coupled to the distal end portion of the housing,the safety lock including a protrusion configured to engage theretention portion of the actuation member to limit movement of theactuation member.
 15. The apparatus of claim 11, further comprising: abiasing member disposed within the second cavity, the biasing memberconfigured to urge the actuation member towards the second position. 16.The apparatus of claim 11, wherein the energy storage member is a gascontainer configured to produce the force when a pressurized gas isreleased from the gas container, the apparatus further comprising: aseal disposed within the second cavity, the seal configured tofluidically isolate a proximal end portion of the second cavity from aregion outside of the housing.
 17. The apparatus of claim 11, wherein:the energy storage member is a gas container configured to produce theforce when a pressurized gas is released from the gas container; and aproximal end portion of the housing defines a flow path such that aproximal end portion of the first cavity is in fluid communication witha proximal end portion of the second cavity.
 18. An apparatus,comprising: a housing defining a first cavity and a second cavity, alongitudinal axis defined by the first cavity offset from a longitudinalaxis defined by the second cavity; a medicament injector movablydisposed within the first cavity, the medicament injector including amedicament container and a needle; an energy storage member disposedwithin second cavity, the energy storage member configured to produce aforce to move the medicament injector to an injection position in whicha portion of the needle is disposed outside of the housing; and anactuator having a release member and a biasing member, the actuatorconfigured to actuate the energy storage member when the release memberis moved from a first position to a second position, the biasing memberdisposed within the second cavity, the biasing member configured to urgethe release member towards the second position.
 19. The apparatus ofclaim 18, wherein: a distal end portion of the housing defines a firstopening in fluid communication with the first cavity and a secondopening in fluid communication with the second cavity; a portion of theneedle is disposed through the first opening when the medicamentinjector is in the injection position; and a portion of the releasemember is disposed through the second opening when the release member isin the first position.
 20. The apparatus of claim 18, wherein therelease member includes a retention portion configured to engage adistal end portion of the housing to limit movement of the releasemember, the apparatus further comprising: a trigger coupled to thedistal end portion of the housing, a portion of the trigger configuredto disengage the retention portion from the distal end portion of thehousing when the trigger is moved relative to the distal end portion ofthe housing.
 21. The apparatus of claim 18, wherein a distal end portionof the housing defines an opening in fluid communication with the secondcavity, a retention portion of the release member is disposed throughthe opening when the release member is in the first position, theapparatus further comprising: a safety lock movably coupled to thedistal end portion of the housing, the safety lock including aprotrusion configured to engage the retention portion of the releasemember to limit movement of the actuation member.
 22. The apparatus ofclaim 18, wherein: the release member is configured to move within thehousing in a first direction when moving from the first position to thesecond position; and the medicament injector is configured to move in asecond direction opposite the first direction when the medicamentinjector is moving toward the injection position.